Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
betamethasone valerate (UNII: 9IFA5XM7R2) (betamethasone valerate - UNII:9IFA5XM7R2)
Rebel Distributors Corp
betamethasone valerate
betamethasone valerate 1 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of cortico-steroid-responsive dermatoses. Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
Betamethasone Valerate Ointment USP, 0.1% is supplied as follows: 45 g tubes NDC 21695-586-45 Store at controlled room temperature 15° - 30°C (59° - 86°F). E. FOUGERA & CO. A division of Nycomed US Inc. Melville, NY 11747 I240D R12/07 #57 Repackaged by: REBEL DISTRIBUTORS CORP THOUSAND OAKS, CA 91320 FOR EXTERNAL USE ONLY NOT FOR OPHTHALMIC USE WARNING: Keep out of reach of children.
Abbreviated New Drug Application
BETAMETHASONE VALERATE- BETAMETHASONE VALERATE OINTMENT REBEL DISTRIBUTORS CORP ---------- BETAMETHASONE VALERATE CREAM USP, 0.1% BETAMETHASONE VALERATE OINTMENT USP, 0.1% BETAMETHASONE VALERATE LOTION USP, 0.1% (POTENCY EXPRESSED AS BETAMETHASONE) RX ONLY For Dermatologic Use Only Not for Ophthalmic Use DESCRIPTION Betamethasone Valerate Cream, Ointment and Lotion contain betamethasone valerate USP, a synthetic adrenocortico-steroid for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Betamethasone valerate is a white to practically white odorless crystalline powder practically insoluble in water, freely soluble in acetone and chloroform, soluble in alcohol, and slightly soluble in benzene and ether. Chemically, it is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17- valerate. The structural formula is: Each gram of the 0.1% Cream contains 1.2 mg betamethasone valerate (equivalent to 1 mg betamethasone) in a soft, white, hydrophilic cream of purified water, mineral oil, white petrolatum, polyethylene glycol 1000 monocetyl ether, cetostearyl alcohol, monobasic sodium phosphate and phosphoric acid or sodium hydroxide; chlorocresol is present as a preservative. Each gram of the 0.1% Ointment contains 1.2 mg betamethasone valerate (equivalent to 1 mg betamethasone) in an ointment base of white petrolatum and mineral oil. Each gram of the 0.1% Lotion contains 1.2 mg betamethasone valerate (equivalent to 1 mg betamethasone) in a vehicle of isopropyl alcohol and water slightly thickened with carbomer 934P. Phosphoric acid or sodium hydroxide is used to adjust pH. CLINICAL PHARMACOLOGY Topical corticosteroids share anti-inflammatory, anti-pruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies Læs hele dokumentet